K232455
- 510(k) number
- K232455
- Device name
- SofWave System
- Applicant
- Sofwave Medical, Ltd. IL
- Product code
- OHV — Focused Ultrasound For Tissue Heat Or Mechanical Cel
- Decision date
- 2023-12-14
- Date received
- 2023-08-14
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Advisory committee
- General, Plastic Surgery
PDFDownload 510(k) SummaryArchived here · 2.5 MB · U.S. public domain
Also available from FDA: K232455.pdf
Official FDA record: K232455
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.